BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3375004 · Received September 30, 2013

    Report

    Report Number
    2954323-2013-00520
    Event Type
    Injury
    Date Received
    September 30, 2013
    Date of Event
    July 6, 2013
    Report Date
    September 6, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, A DEVICE HISTORY REVIEW (DHR) OF THE METER WAS REQUESTED. THE DHR FOR METER SERIAL NUMBER (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. HOWEVER, ONLY THE METER WILL BE RETURNED SINCE THE CUSTOMER NO LONGER HAS THE TEST STRIPS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ACCORDING TO LABEL COPY, IT STATES USE ONLY WITH FREESTYLE LITE TEST STRIPS AND THAT OTHER PRODUCTS CAN PRODUCE INACCURATE RESULTS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 2 MONTHS AGO SHE RECEIVED A READING OF 61 MG/DL AND ON THEIR ADC METER AND EXPERIENCED WEIGHT LOSS. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS GIVEN "A SHOT TO BRING HER SUGAR UP." THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE THEY WERE DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND AN IV WAS PLACED. IN ADDITION, THE CUSTOMER WAS GIVEN SOMETHING TO EAT. THE HOSPITAL MONITORED HER SUGAR LEVEL AND BLOOD PRESSURE WHICH WAS 150/100. IT SHOULD BE NOTED THAT THE CUSTOMER REPORTED EXPERIENCING A LOSS OF APPETITE, SWEATINESS, ANXIETY, SHAKINESS AND DIZZINESS FOR THE LAST 5 MONTHS AND HAS BEEN USING INCOMPATIBLE TEST STRIPS FOR ABOUT A YEAR AND A HALF AND SHE DOES NOT KNOW IF SHE IS GETTING A CORRECT READING. THE CUSTOMER FURTHER REPORTED THEY NOW HAVE COMPATIBLE TESTS STRIPS FOR THEIR ADC METER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491888 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention